RAICHEM GLUCOSE UV (LIQUID)

K041052 · Hemagen Diagnostics, Inc. · CFR · Jun 30, 2004 · Clinical Chemistry

Device Facts

• Record ID: K041052
• Device Name: RAICHEM GLUCOSE UV (LIQUID)
• Applicant: Hemagen Diagnostics, Inc.
• Product Code: CFR · Clinical Chemistry
• Decision Date: Jun 30, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

This reagent is intended for the quantitative enzymatic determination of glucose in serum or plasma. For in vitro diagnostic use only. This glucose test system is a device intended to measure glucose quantitatively in serum or plasma. Glucose measurements are used in the diagnosis and treatment of diabetes mellitus, idiopathic hypoglycemia, and of pancreatic islet cell tumors.

Device Story

In vitro diagnostic reagent kit for quantitative glucose measurement in serum or plasma; utilizes enzymatic hexokinase/G-6-PDH methodology. Device consists of two ready-to-use liquid reagents containing magnesium, NAD, ATP, hexokinase, and G-6-PDH. Operated on Roche COBAS Mira Chemistry System in clinical laboratory settings. Principle: glucose phosphorylation by hexokinase produces G-6-P; G-6-PDH oxidizes G-6-P to 6-phosphogluconate, reducing NAD to NADH. NADH absorbance measured at 340 nm; absorbance increase directly proportional to glucose concentration. Output provides quantitative glucose levels to clinicians for diagnosing/treating metabolic disorders. Benefits include accurate glucose monitoring for diabetes and hypoglycemia management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Quantitative enzymatic assay. Reagents: magnesium, NAD, ATP, hexokinase, G-6-PDH, buffers, stabilizers. Sensing: spectrophotometric (340 nm). Form factor: liquid reagents. Connectivity: automated analyzer (Roche COBAS Mira). Stability: 18 months unopened; 9-11 days on-board.

Indications for Use

Indicated for quantitative glucose measurement in serum or plasma for diagnosis and treatment of carbohydrate metabolism disorders (diabetes mellitus, neonatal/idiopathic hypoglycemia, pancreatic islet cell tumors) in adult, pediatric, and neonatal populations.

Regulatory Classification

Identification

A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Special Controls

*Classification.* Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/0/Picture/2 description: The image shows the seal of the Department of Health & Human Services USA. The seal features an abstract eagle design with three stylized wing strokes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 3 0 2004

Mr. James J. Miller Official Correspondent General Manager Hemagen Diagnostics, Inc. Raichem Division 9033 Red Branch Road Columbia, MD 21045

k041052 Re:

Trade/Device Name: Glucose test System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: CFR Dated: March 5, 2004 Received: April 19, 2004

Dear Mr. Miller:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your be determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enactment date of the Medical Device Amendments, or to conner of the that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmetic For (10) that the device, subject to the general controls provisions of the Act. The I ou may, morelor, mains of the Act include requirements for annual registration, listing of general vontrols proficiouring practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it your device to such additional controls. Existing major regulations affecting your device it may be subject to bach additions (CFR), Parts 800 to 895. In additions (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I least of advised that I Dr brissantly wour device complies with other requirements of the Act that I DA has made a acterimalations administered by other Federal agencies. You must or any 1 cataled and the Act's requirements, including, but not limited to: registration and listing (21 Comply with and the tree (21 CFR Parts 801 and 809); and good manufacturing practice Of It I art 807), as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Jean M. Cooper, MS, DVM.
MS, DVM

Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K041052

Device Name: Glucose test system

Indications For Use:

This reagent is intended for the quantitative enzymatic determination of glucose in serum or plasma. For in vitro diagnostic use only.

This glucose test system is a device intended to measure glucose quantitatively in I his glucose tool oyotom to a casurements are used in the diagnosis and treatment of Scrum or plasma. Glass and idiopathic hypoglycemia, and of pancreatic islet cell tumors.

The intended patient population may be adult, pediatric, and neonatal.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol C Benson
Division Sign-Off

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510/k)

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